Company: Sunquest Information Systems, IncDate of Enforcement Report: 2/13/02 Class: II PRODUCT FlexiLab? Laboratory Information System, Recall # B-0710-2. REASON Blood bank computer system, which had a software glitch or defect, was distributed. CODE Versions 5.23 and 5.3 with RBR module. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., Tucson, AZ, by letter dated March 19, 2001....Read More

Company: Sunquest Information Systems, Inc Date of Enforcement Report: 2/13/02 Class: II PRODUCT FlexiLab? Blood Bank and Blood Donor Software, Recall # B-0711-2. REASON Blood bank computer system, which had a software glitch or defect, was distributed. CODE Versions 5.2 and 5.23. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., Tucson, AZ, by letter dated June 22,...Read More

Company: Sunquest Information Systems, IncDate of Enforcement Report: 2/13/2002 Class: II PRODUCT FlexiLab? Blood Bank and Blood Donor Software, Recall # B-0709-2. REASON Blood bank computer system, which had a software glitch or defect, was distributed. CODE Versions 5.2, 5.23 and 5.3. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., Tucson, AZ, by letter dated March 13,...Read More

Company: Roche Diagnostics CorpDate of Enforcement Report: 2/6/02 Class: II PRODUCT All DataCare Systems Software, as follows: A) DataCare Server/Workstation Computer for DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog GD9200. Sold in the U.S. B) DataCare Networked Client Computer for DataCare ABG Data Management System...Read More

Company: Mediware Information Systems, IncDate of Enforcement Report: 2/30/02 Class: III PRODUCT Hemocare Blood Bank Data Management System Software, Recall # B-0626-2. REASON Computer software that could allow the assignment of an extended expiration date to blood products was distributed. CODE Versions 5.1, 5.2, 5.2a, and 5.2b. RECALLING FIRM/MANUFACTURER Mediware Information Systems, Inc., Melville, NY...Read More

Company: Dade Behring, IncDate of Enforcement Report: 1/30/02 Class: II PRODUCT Dimension Clinical Chemical Analyzer XL/RxL/ARx with software revision 5.2, Recall # Z-0433-02. REASON Instructions to software revision are missing a step. CODE Revision 5.2 The following serial numbers are involved in the recall: 971807, 973002, 970457, 973278, 970598, 970454, 970049, 971979, 973242, 970864, 973218,...Read More

Company: Biochem Immunosystems (U.S.), IncDate of Enforcement Report: 1/23/02 Class: II PRODUCT Personal Lab Version 2.2a. The device is an Immunochemistry Analyzer Open System, Recall # Z-0463-02. REASON Samples were not picked up and added to the dilution tube. CODE Version 2.2a Catalog # PL01. RECALLING FIRM/MANUFACTURER Recalling Firm: Biochem Immunosystems (U.S.), Inc. Allentown, PA,...Read More

Company: Mediware Information Systems, IncDate of Enforcement Report: 1/23/02 Class: II PRODUCT Hemocare Blood Bank Data Management System, Recall # B-0670-2. REASON Defects in the design of blood bank software programs could result in the release of unsuitable blood products. CODE Version 5.1, 5.2 and/or 5.2a. RECALLING FIRM/MANUFACTURER Mediware Information Systems, Inc., Melville, NY, by...Read More

Company: Mediware Information Systems, IncDate of Enforcement Report: 1/23/02 Class: II PRODUCT Hemocare Blood Bank Data Management System, Recall # B-0668-2. REASON Defects in the design of blood bank software programs could result in the release of unsuitable blood products. CODE Version 5.1, 5.2 and/or 5.2a. RECALLING FIRM/MANUFACTURER Mediware Information Systems, Inc., Melville, NY, by...Read More

Company: Mediware Information Systems, IncDate of Enforcement Report: 1/23/02 Class: 111 PRODUCT Hemocare Blood Bank Data Management System, Recall # B-0671-2. REASON Defects in the design of blood bank software programs could result in the release of unsuitable blood products. CODE Version 5.1, 5.2 and/or 5.2a. RECALLING FIRM/MANUFACTURER Mediware Information Systems, Inc., Melville, NY, by...Read More

Company: Mediware Information Systems, Inc.Date of Enforcement Report: 1/23/02 Class: III PRODUCT Hemocare Blood Bank Data Management System, Recall # B-0669-2. REASON Defects in the design of blood bank software programs could result in the release of unsuitable blood products. CODE Version 5.1, 5.2 and/or 5.2a. RECALLING FIRM/MANUFACTURER Mediware Information Systems, Inc., Melville, NY, by...Read More

Company: Mediware Information Systems, Inc.Date of Enforcement Report: 1/23/02 Class: III PRODUCT Hemocare Blood Bank Data Management System, Recall # B-0667-2. REASON Defects in the design of blood bank software programs could result in the release of unsuitable blood products. CODE Version 5.1, 5.2 and/or 5.2a. RECALLING FIRM/MANUFACTURER Mediware Information Systems, Inc., Melville, NY, by...Read More

Company: Mediware Information Systems, IncDate of Enforcement Report: 1/23/02 Class: III PRODUCT Hemocare Blood Bank Data Management System, Recall # B-0666-2. REASON Defects in the design of blood bank software programs could result in the release of unsuitable blood products. CODE Version 5.1, 5.2 and/or 5.2a. RECALLING FIRM/MANUFACTURER Mediware Information Systems, Inc., Melville, NY, by...Read More

Company: Sunquest Information Systems, IncDate of Enforcement Report: 1/23/02 Class: II PRODUCT FlexiLab? Blood Bank and Blood Donor Software (3 versions), Recall # B-0627-2. REASON Blood establishment computer software that could allow the release of unsuitable blood products was distributed. CODE Version numbers 5.2, 5.23, and 5.3. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., Tucson, AZ,...Read More

Company: Siemens Medical Systems, IncDate of Enforcement Report: 1/16/02 Class: III PRODUCT Autoperfusion Software used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems to conduct automated myocardial processing in diagnosing myocardial disease in cardiac SPECT studies. Recall # Z-0427-02. REASON The software did not save oblique data correctly...Read More

Company: Siemens Medical Systems, INCDate of Enforcement Report: 11/16/01 Class: III PRODUCT Autoperfusion Software, which includes The Cardiac Review (Profile Review) application, used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems to conduct automated myocardial processing in diagnosing myocardial disease in cardiac SPECT studies. Recall # Z-0428-02. REASON...Read More

Company: Multidata Systems International Corp.Date of Enforcement Report: 11/28/01 Class: II PRODUCT Radiation Treatment Planning Decision Support System (DSS), Recall # Z-0213-2. REASON The software calculates radiation overdoses that require human intervention to detect and prevent injury to radiation therapy patients. CODE All versions. RECALLING FIRM/MANUFACTURER Multidata Systems International Corp., St. Louis, MO, by letter...Read More

Company: Abbott Laboratories, IncDate of Enforcement Report: 11/28/01 Class: II PRODUCT The Abbott AxSYM System is a fully automated Immunoassay analyzer designed to perform Microparticle Enzyme Immunoassay (MEIA), Fluorescence Polarization Immunoassay (FPIA), Radiative Energy Attenuation (REA) Assay Technology, and Ion Capture (IC) Immunoassay Technologies. The AxSYM System performs random access, continuous access, and STAT processing...Read More

Company: Radionics, A Division of Tyco HealthcareDate of Enforcement Report: 11/21/01 Class: II PRODUCT Radionics XKnife RT Software, Recall # Z-0275-2. REASON Software error may cause incorrect jaw settings for a record/verify system. CODE Version 1.02 and lower. RECALLING FIRM/ MANFACTURER Radionics, A Division of Tyco Healthcare, Billerica, MA, by telephonebetween 9/17/2001 and 18/01. Firm...Read More

Company: Novametrix Medical Systems, IncDate of Enforcement Report: 11/7/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0216-2, Novametrix NICO Monitor, Model 7300 with software versions below 4.3 REASON: Monitor may miscalculate Pulse Rate and Oxygen Saturation (SpO2) values. MANUFACTURER/RECALLING FIRM: Novametrix Medical Systems, Inc., Wallingford, CT RECALLED BY: Recalling firm by letter on 7/9/01 FIRM...Read More

Company: Marconi Medical Systems, IncClass: II Date of Enforcement Report: 10/31/01 RECALL NUMBER, PRODUCT AND CODE: Z-0181-2, Marconi MX8000 Computed Tomography X-ray System, Codes: All Marconi MX8000 CT Scanners, running with Version 2.0 and 2.01 software. REASON: Software in version 2.0 / 2.01 software may lead to improper patient treatment. MANUFACTURER/RECALLING FIRM: Marconi Medical Systems,...Read More

Company: Dade Behring Marburg GMBHDate of Enforcement Report: 10/24/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0013-2, Behring Coagulation System (BCS) Coagulation Analyzer. Codes: Software Version 2.2 Code OVIO03 REASON: Falsely shortened APTT value. MANUFACTURER/RECALLING FIRM: Dade Behring Marburg GMBH, Marburg, Germany RECALLED BY: Dade Behring, Inc., Newark, DE, by letter on 6/25/01 FIRM INITIATED...Read More

Company: Marconi Medical Systems, IncDate of Enforcement Report: 10/24/01 Class: III RECALL NUMBER, PRODUCT AND CODE: Z-0057-2, Marconi MX8000 Computed Tomography X-ray Codes: All Marconi MX8000 CT Scanners running with Version 2.0 sofware. REASON: A software anomaly in ver 2.0 software may result in improper patient diagnosis. MANUFACTURER/RECALLING FIRM: Marconi Medical Systems, Inc., Highland Heights,...Read More

Company: Nihon Kohden, IncDate of Enforcement Report: 10/24/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0177-2/Z-0178-2, Procyon Bedside Monitors, Models BSM-4104A and BSM- 4114A. Codes: Models BSM-4104A and BSM-4114A Bedside Monitors. REASON: Software causes infusion rate 2.2 times proper rate. MANUFACTURER/RECALLING FIRM: Nihon Kohden, Inc., CA RECALLED BY: Recalling firm by telephone and letter on...Read More

Company: Siemens Medical Systems, IncDate of Enforcement Report: 10/24/01 Class: III RECALL NUMBER, PRODUCT AND CODE: Z-0031-2, Motion Electronics Computer Chassis (MECC) Backplanes installed in E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL Codes: MECC Backplane “2104938 REV C” —...Read More

Company: TegimentaDate of Enforcement Report: 10/17/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0008-2, COBAS Integra 400 laboratory clinical chemistry analyzer, Model 400, Catalog number 1045199. All serial numbers of analyzers lower than 38-2606. Serial numbers of 38-2606 or higher have already been updated with software revision upgrade 4. REASON: If the operator fails to...Read More

Company: Bayer CorporationDate of Enforcement Report: 10/10/01 Class: III RECALL NUMBER, PRODUCT AND CODE: Z-1223-1, Software versions AE through AL (except AI) for the Bayer Advia Centaur Automated Chemiluminescence Immunoassay System. The affected software was distributed as a component of the Advia Centaur Automated Chemiluminescence Immunoassay system. Codes: Software versions AE through AL, except version...Read More

Company: SIEMENS MEDICAL SYSTEMS, INCDate of Enforcement Report: 9/19/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-1106-1 – Z-1108-1 Programmable Multi-Axis Controller (PMAC 2 Lite) circuit board installed in E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Codes: a) Model 4380213 – E.CAM Gantry Single Head, serial numbers 0001 through...Read More

Company: Applicare Medical ImagingDate of Enforcement Report: 9/12/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0857-1/Z-0858-1 RadWorks Software Version 5.1 with Software Patch 5 or 7, and RadWorks WebViewer Software Verion 5.1 running on RadWorks 5.1 Software Patch 5 or 7; picture archival and communications system; Applicare Medical Imaging B.V., Zeist, The Netherlands Codes: RadWorks...Read More

Company: WELCH ALLYN PROTOCOL, INCDate of Enforcement Report: 9/12/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-1049-1 Acuity Central Monitoring Stations with software versions 4.03.00, 4.03.01,4.03.02, 4.03.03, 4.03.04, and 4.03.05 when connected to VHF/UHF telemetry units CODES: software versions 4.03.00, 4.03.01, 4.03.02, 4.03.03, 4.03.04, and 4.03.05 REASON: Incorrect Visual Display MANUFACTURER/RECALLING FIRM: WELCH ALLYN PROTOCOL,...Read More

Company: Dade Behring Marburg GMBH MarburgDate of Enforcement Report: 9/12/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0906-1 Behring Coagulation System (BCS) software CODES: Model OVIO03, Version 2.2 REASON: Leak of piston pump valve introduces air bubbles. MANUFACTURER/RECALLING FIRM: Dade Behring Marburg GMBH Marburg RECALLED BY: Dade Behring, Inc., Newark, DE, by letter. FIRM INITIATED...Read More

Company: SIEMENS MEDICAL SYSTEMS, INC.Date of Enforcement Report: 9/12/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-1105-1/Z-1107-1 Programmable Multi-Axis Controller (PMAC 2 Lite) circuit board installed in E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine proceduresCodes: a) Model 4380213 – E.CAM Gantry Single Head, serial numbers 0001 thru 2016 b) Model...Read More

Company: SANGUIN INTL., INCDate of Enforcement Report: 9/12/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-1048-1 Medusa 2000 MED20SP Link Software Versions 1.2 and 1.3 The software Medusa 2000 is an interface link to the Ortho Summit Processor (OSP) which is a mass processing device for microplate based assays [tests for viral markers by ELISA]....Read More

Company: GE Medical Systems, Information TechnologiesDate of Enforcement Report: 9/12/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-1078-1 Clinical Information Center Software. The brand name was Marquette when the product was initially distributed. CODES: All devices with V.2 and later revisions of the software. REASON: Device can improperly restart resulting in no alarms or information...Read More

Compnay: Siemens Medical Systems, IncDate of Enforcement Report: 9/12/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0851-1 ICON Profile Processing Software used on the ICON P workstations designed for use with E.CAM Gamma Camera Systems to conduct cardiac Tomo and SPECT applications; 60195-5203. Codes: All E.CAM gamma cameras with the Profile option with ICON-P workstations...Read More

Company: Baxter Healthcare CorporationDate of Enforcement Report: 9/5/01 Class: II RECALL NUMBER, PRODUCT AND CODE: B-1332-1, Amicus Separator Apheresis Instrument with software version 2.50 REASON: Blood collection device may return an inappropriate volume of plasma to a donor during an apheresis procedure. MANUFACTURER: Baxter Healthcare Corporation, Largo, FL RECALLED BY: Baxter Healthcare Corp., Round Lake,...Read More

Company: Siemens Medical Systems, Inc.Date of Enforcement Report: 9/5/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0769-1 – Z-0771-1 E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL 60195-5203 CODES: a) E.CAM+ models with e.soft workstations, e.soft software versions 1.0 and...Read More

Company: Dade Behring Marburg GMBH MarburgDate of Enforcement Report: 9/5/01 Class: III RECALL NUMBER, PRODUCT AND CODE: Z-0906-1 Behring Coagulation System (BCS) software version 2.2. REASON: Leak of piston pump valve introduces air bubbles. CODES: Model OVIO03 Version 2.2 MANUFACTURER/RECALLING FIRM: Dade Behring Marburg GMBH Marburg RECALLED BY: Dade Behring, INC., Newark, DE., by letter...Read More

Company: DADE BEHRING, INCDate of Enforcement Report: 9/5/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0913-1, Dimension RxL, Clinical Chemical Analyzer, RxL/HM with software, 5.1 REASON: Incorrect low results for a number of patient samples. CODE: Version 5.1 MANUFACTURER: DADE BEHRING, INC., NEWARK, DE RECALLED BY: Manufacturer, by letter 4/9/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION:...Read More

Company: AGILENT TECHNOLGIES Date of Enforcement Report: 9/5/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0948-01/Z-0949-01 Agilent Technologies (formerly Hewlett Packard Co.) (A)Anesthesia Monitoring Systems, M1165A, M1166A, M1167A, M1175A, M1176A, M1177A with Release C.0 software and Options A74, A76, A84, A86 specifying Care Models: 74S, 76S, 84S, 86S Firmware Revision level: Only EEPROM Nos.: M1059-81242...Read More

Company: Medica Corp.Date of Enforcement Report: 9/5/01 Class: III RECALL NUMBER, PRODUCT AND CODE: Z-0951-1 EasyBlood Gas Analyzer. REASON: PCO2 and PO2 values are incorrect if displayed in SI units instead of mmHg. CODES: EasyBlood Gas Analyzers with Software version below M4.20. MANUFACTURER/RECALLING FIRM: Medica Corp., Bedford, MA. RECALLED BY: Manufacturer, by fax on 8/15/00....Read More

DATE RECALL INITIATED< br> August 24, 2001 PRODUCT / LOT NUMBER / EXPIRATION DATE: FlexiLab Blood Bank and Blood Donor Software, Software versions 5.2, 5.23, and 5.3 MANUFACTURER: Sunquest Information Systems, Inc. Tucson, AZ REASON: A software defect has the potential to result in blood components/derivates reaching inventory “Available Inventory Status” without a product testing...Read More

Company: DADE BEHRING MARBURGDate of Enforcement Repor: 8/22/01t Class: III RECALL NUMBER, PRODUCT AND CODE: Z-0906-1, Behring Coagulation System (BCS) software version 2.2 REASON: Leak of piston pump valve introduces air bubbles MANUFACTURER: DADE BEHRING MARBURG, Germany RECALLED BY: DADE BEHRING, INC., GLASGOW, DE, by letter to the three accounts informing them of the problem...Read More

Company: SUNQUEST INFORMATION SYSTEMS, INCDate of Enforcement Report: 8/22/01 Class: III RECALL NUMBER, PRODUCT AND CODE: Z-0733-1, FlexiLab Laboratory Information System Version 5.2, 5.23, and 5.3 interfaced with Anatomic Pathology Lab Access Transcription Workstation. REASON: Software glitch MANUFACTURER/RECALLING FIRM: SUNQUEST INFORMATION SYSTEMS, INC., TUCSON, AZ RECALLED BY: A temporary procedural workaround was communicated to all...Read More

Company: DADE BEHRING, INC.Date of Enforcement Report: 8/22/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0913-1, Dimension RxL, Clinical Chemical Analyzer, RxL/HM with software version 5.1 REASON: Incorrect low results for a number of patient samples MANUFACTURER/RECALLING FIRM: DADE BEHRING, INC., Newark, DE RECALLED BY: Manufacturer, by letter on 4/9/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION:...Read More

Company: ALARIS MEDICAL SYSTEMS, INCDate of Enforcement Report: 8/22/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-748-1, Model PC-1 A one channel, general purpose, infusion pump, 220V CE Marked, International only (Software version 8.12 and 8.13) REASON: Motor stall MANUFACTURER/RECALLING FIRM: ALARIS MEDICAL SYSTEMS, INC., San Diego, CA RECALLED BY: International mailings are being coordinated...Read More

Company: SUNQUEST INFORMATION SYSTEMS, INCDate of Enforcement Report Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0735-1, FlexiLab Laboratory Information System, Version 5.23 REASON: Software anomaly MANUFACTURER/RECALLING FIRM: SUNQUEST INFORMATION SYSTEMS, INC., Tucson AZ RECALLED BY: A temporary procedural workaround was communicated to all affected customers in Product Safety Notice PSN-01-L18, June 8, 2001. FIRM INITIATED...Read More

Company: SONOSITE, INCDate of Enforcement Report: 8/22/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-868-1, Sonosite 180 – portable, software controlled ultrasound system intended for use with a variety of transducers to perform a variety of scans and measurements/calculations for the abdomen, pediatric scans, general cardiac, GYN/infertility, obstetrics. Code: Sonosite units with the following software...Read More

Date Recall Initiated:July 20, 2001 Product: Solar 9500 Physiological ECG Monitor Use: To monitor patient vital signs including blood pressure, pulse, temperature, cardiac output, respiration, and anesthetic gas concentrations during surgery. This product is intended for use under the direct supervision of a licensed health care practitioner. Reason for Recall: Incorrect computer chips were installed...Read More

Company: Toshiba America Medical Systems, Inc.Date of Enforcement Report: 7/18/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0690-1, Impax Technology Inc. DDS Intended use is as Diagnostic Image Display Software Model/catalog number: DS3000, CS5000, XA3000 REASON: Wrong image presents to radiologist upon database query. MANUFACTURER/RECALLING FIRM: Toshiba America Medical Systems, Inc., Tustin, CA RECALL BY:...Read More